FH-047 (ANGELUS) Page 1 of 26. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 26 REGISTRATION REPORT Part A Risk Management Product code: FH-047 Product name: ANGELUS Active substance: clomazone 360 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation)

2 Page 2 of 26 Table of Contents 1 DETAILS OF THE APPLICATION APPLICATION BACKGROUND ACTIVE SUBSTANCE APPROVAL REGULATORY APPROACH DATA PROTECTION CLAIMS LETTER(S) OF ACCESS DETAILS OF THE AUTHORISATION PRODUCT IDENTITY CLASSIFICATION AND LABELLING Classification and labelling under Directive 99/45/EC Classification and labelling in accordance with Regulation (EC) No1272/ Other phrases in compliance with Regulation (EU) No 547/ Other phrases linked to the preparation PRODUCT USES RISK MANAGEMENT REASONED STATEMENT OF THE OVERALL CONCLUSIONS TAKEN IN ACCORDANCE WITH THE UNIFORM PRINCIPLES Physical and chemical properties Methods of analysis Mammalian Toxicology Residues and Consumer Exposure Environmental fate and behaviour Ecotoxicology Efficacy CONCLUSIONS ARISING FROM FRENCH ASSESSMENT SUBSTANCES OF CONCERN FOR NATIONAL MONITORING FURTHER INFORMATION TO PERMIT A DECISION TO BE MADE OR TO SUPPORT A REVIEW OF THE CONDITIONS AND RESTRICTIONS ASSOCIATED WITH THE AUTHORISATION Post-authorisation monitoring Post-authorisation data requirements Label amendments APPENDIX 1 COPY OF THE FRENCH DECISION APPENDIX 2 COPY OF THE DRAFT PRODUCT LABEL AS PROPOSED BY THE APPLICANT APPENDIX 3 LETTER(S) OF ACCESS... 26

3 Page 3 of 26 PART A Risk Management The company ROTAM AGROCHEMICAL EUROPE LIMITED has requested marketing authorisation in France for the product ANGELUS (formulation code: FH-047), containing 360 g/l clomazone, for use as a herbicide. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C, and where appropriate the addenda for France. The information, data and assessments provided in Registration Report, Part B include assessment of further data or information as required at national registration by the EU peer review. It also includes assessment of data and information relating to ANGELUS (FH-047) where those data have not been considered in the EU peer review process. Otherwise assessments for the safe use of ANGELUS (FH-047) have been made using endpoints agreed in the EU peer review of clomazone. This document describes the specific conditions of use and labelling required for France for the registration of ANGELUS (FH-047). Appendix 1 of this document provides a copy of the French Decision. Appendix 2 of this document is a copy of the draft product label as proposed by the applicant. Appendix 3 of this document is a copy of the letter(s) of Access. 1 DETAILS OF THE APPLICATION 1.1 Application background The present registration report concerns the evaluation of ROTAM AGROCHEMICAL EUROPE LIMITED s application to market ANGELUS (FH-047) in France as a herbicide (product uses described under point 2.3). France acted as zonal Rapporteur Member State (zrms) for this request and assessed the application submitted for the first authorisation of this product in France and in other MSs of the Southern zone. 1.2 Active substance approval Clomazone Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. Specific provisions of Regulation (EU) No 540/2011 were as follows : PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: - The operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, - The protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones. An EFSA conclusion is available (EFSA Scientific Report (2007) 109, 1-73). A Review Report is available (SANCO/2823/07 rev 2, 10 September 2007).

4 Page 4 of Regulatory approach The present application ( ) was evaluated in France by the French Agency for Food, Environmental and Occupational Health & Safety (Anses) 1 in the context of the zonal procedure for all Member States of the Southern zone, taking into account the worst-case uses ( risk envelope approach ) 2 the highest application rates over the. When risk mitigation measures were necessary, they are adapted to the situation in France. The French Order of 4th May provides that: - unless formally stated in the product authorisation, the pre harvest interval (PHI) is at least three days; - unless formally stated in the product authorisation, the minimum buffer zone alongside a water body is five metres; - unless formally stated in the product authorisation, the minimum re-entry period is six hours for field uses and eight hours for indoor uses. Drift reduction measures such as low-drift nozzles are not considered within the decision-making process in France. However, drift buffer zones may be reduced under some circumstances as explained in Appendix 3 of the abovementioned French Order. The current document (RR) based on Anses s assessment of the application submitted for this product is in compliance with Regulation (EC) no 1107/2009 4, implementing regulations, and French regulations. The data taken into account are those deemed to be valid either at European Union level or at zonal/national level. This part A of the RR presents a summary of essential scientific points upon which recommendations are based and is not intended to show the assessment in detail. The conclusions relating to the acceptability of risk are based on the criteria indicated in Regulation (EU) No 546/2011 5, and are expressed as acceptable or not acceptable in accordance with those criteria. Finally, the French Order of 26 March provides that: - an authorisation granted for a reference crop applies also for linked crops, unless formally stated in the Decision - the reference and linked crops are defined in Appendix 1 of that French Order. Thus, at French national level, possible extrapolation of submitted data and the corresponding assessment from reference crops to linked ones are undertaken even if not clearly requested by the applicant in their drr, and a conclusion is reached on the acceptability of the intended uses on those linked crops. The aim of this Order, mainly based on the EU document on residue data extrapolation 7 is to supply minor crops with registered plant protection products. Therefore the GAP table (Section 2.3) and Decision may include uses on crops not originally requested by the applicant. The Decision, as reproduced in Appendix 1, takes also into account national provisions, including national mitigation measures. 1.4 Data protection claims French Food Safety Agency, Afssa, before 1 July 2010 SANCO document risk envelope approach, European Commission (14 March 2011). Guidance document on the preparation and submission of dossiers for plant protection products according to the risk envelope approach ; SANCO/11244/2011 rev. 5 Arrêté du 4 mai 2017 relatif à la mise sur le marché et à l'utilisation des produits phytopharmaceutiques et de leurs adjuvants visés à l'article L du code rural et de la pêche maritime REGULATION (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC COMMISSION REGULATION (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products SANCO document guidance document:- Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs : SANCO/ 7525/VI/95 - rev.9

5 Page 5 of 26 Where protection for data is being claimed for information supporting registration of ANGELUS (FH-047), it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections Letter(s) of Access Not necessary: the applicant has provided sufficient data to show that access is not required.

6 Page 6 of 26 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) Authorisation number Function Applicant Composition Formulation type (code) ANGELUS (FH-047) Herbicide Rotam Agrochemical Europe Ltd. 360 g/l clomazone Capsule suspension (CS) Packaging HDPE bottles (1 L) and HDPE containers (5 L and 10 L) 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC Not applicable after 1st June Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards Acute toxicity (inhalation), Hazard Category 4 Environmental hazards Hazard pictograms Skin irritation, Hazard Category 2 Eye irritation, Hazard Category 2 - Signal word Warning Hazard statements H315 Causes skin irritation H319 Causes serious eye irritation H332 Harmful if inhaled Precautionary statements For the P phrases, refer to the extant legislation Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) EUH208 Contains diethylenetriamine, ethylenediamine and 1,2-benzisothiazol-3(2H)- one. May produce an allergic reaction. See Part C for justifications of the classification and labelling proposals.

7 Page 7 of Other phrases in compliance with Regulation (EU) No 547/2011 The authorisation of the preparation is linked for professional uses only to the following conditions: SP 1 SPe 3 Do not contaminate water with the product or its container. Do not clean application equipment near surface water. Avoid contamination via drains from farmyards and roads. To protect aquatic organisms, respect an unsprayed buffer zone of 5 metres 8 to surface water bodies Other phrases linked to the preparation Wear suitable personal protective equipment 9 : refer to the Decision in Appendix 1 for the details Re-entry period 10 : 24 hours Pre-harvest interval 11 : - Oilseed rape, borage, turnip rape, gold-of-pleasure, white mustard, sesame, linseed, hemp: F - Application must be made at growth stage BBCH 05 at the latest - Potato: F - Application must be made at growth stage BBCH 07 at the latest Other mitigation measures: - In the case of a crop failure, do not grow a short-cycle crop (approximately 30 days between sowing/planting and harvest) in the treated plot less than 90 days after an application of clomazone.. The label must reflect the conditions of authorisation The legal basis for this is Titre III Article 12 of the French Order of 4th May 2017 concerning the marketing and use of products encompassed by article L of the rural code [that is, plant protection products/pesticides] If a tractor with cab is used, wearing gloves during application is only required when working with the spray mixture The legal basis for this is Titre I Article 3 of the French Order of 4th May 2017 concerning the marketing and use of products encompassed by article L of the rural code [that is, plant protection products/pesticides] According to the French Order of 4th May 2017, PHI cannot be lower than 3 days unless specifically stated in the assessment and decision.

8 Page 8 of Product uses Please note: The GAP Table below reports the intended uses proposed by the applicant, and possible extrapolation according to French Order of 26 March 2014 (highlighted in green) evaluated and concluded as safe uses by France as zrms. Those uses are then granted in France. (a, b) PPP (product name/code): ANGELUS (FH-047) Formulation type: CS Active substance 1: clomazone Conc. of a.s. 1: 360 g/l (c) Professional use: Zone(s): southern (d) Non-professional use: Verified by MS: Field of use: yes herbicide GAP, date: 29/06/ Use- No. (e) Member state(s) Crop and/ or situation (crop destination / purpose of crop) F, Fn, Fpn G, Gn, Gpn or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Zonal uses (field or outdoor uses, certain types of protected crops) 1 France Oilseed rape, borage, turnip rape, gold-of-pleasure, white mustard, sesame, linseed, hemp 2 France Potato F F Dicotyledonous and monocotyledonous weeds TTTDS, TTTMS Dicotyledonous and monocotyledonous weeds TTTDS, TTTMS Method / Kind Overall spraying Overall spraying Timing / Growth stage of crop & season BBCH d after drilling at the latest. BBCH d after drilling at the latest. Application Max. number Min. interval Application rate g a.s./ha Water PHI (days) a) per use between L/ha b) per crop/ applications season (days) a) 1 b) 1 a) 1 b) 1 a) 1 b) 1 a) 1 b) 1 kg or L product / ha a) max. rate per appl. b) max. total rate per crop/season a) 0.33 b) 0.33 a) 0.25 b) 0.25 a) max. rate per appl. b) max. total rate per crop/season a) 120 b) 120 a) 90 b) 90 min / max N/A N/A Remarks: e.g. g safener/synergist per ha (f) Acceptable Acceptable Remarks table heading: (a) (b) (c) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR), capsule suspension (CS) Catalogue of pesticide formulation types and international coding system CropLife International Technical Monograph n 2, 6th Edition Revised May 2008 g/kg or g/l (d) (e) (f) Select relevant Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.

9 Page 9 of 26 Remarks columns: 1 Numeration necessary to allow references 2 Use official codes/nomenclatures of EU Member States 3 For crops, the EU and Codex classifications (both) should be used; when relevant, the use situation should be described (e.g. fumigation of a structure) 4 F: professional field use, Fn: non-professional field use, Fpn: professional and nonprofessional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the common names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi, weeds) and the developmental stages of the pests and pest groups at the moment of application must be named. 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated. 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application 8 The maximum number of application possible under practical conditions of use must be provided. 9 Minimum interval (in days) between applications of the same product 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, kg or L product / ha). 12 If water volume range depends on application equipments (e.g. ULVA or LVA) it should be mentioned under application: method/kind. 13 PHI - minimum pre-harvest interval 14 Remarks may include: Extent of use/economic importance/restrictions

10 Page 10 of 26 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties ANGELUS (FH-047) is a pale beige liquid, capsule suspension formulation, containing 360 g/l clomazone. All studies have been performed in accordance with the current requirements and the results are deemed acceptable. It is not explosive and has no oxidising properties. The product has a flash point of 88 C and a self-ignition temperature of 406 C. In aqueous solution (1%), it has a ph value of 7.4 at 25 C. There is no effect of low and high temperatures on the stability of the formulation, since after four cycles with 18 h at -10 ± 2 C and 6 h at 20 ± 2 C and 14 days at 54 C, neither the active substance content nor the technical properties were changed. The stability data indicate a shelf life of at least two years at ambient temperature when stored in a HDPE bottle. Its technical characteristics are acceptable for a CS formulation. The formulation is not classified for the physical-chemical aspect Methods of analysis Analytical method for the formulation Analytical methodology for the determination of total active substance in the formulation is available and validated. Validation of the analytical method for the determination of free clomazone in the preparation is required postauthorisation with a submission deadline of two years. As the active substance clomazone does not contain any relevant impurity, no pertinent analytical method is required Analytical methods for residues Analytical methods are available in the Draft Assessment Report (DAR) and in this dossier and validated for the determination of residues of clomazone in plants (oily crops), foodstuffs of animal origin, soil, water (surface and drinking) and air. The active substance is neither toxic nor very toxic, hence no analytical method is required for the determination of residues in biological fluids and tissues Mammalian Toxicology Endpoints used in risk assessment Active substance: clomazone ADI ARfD mg/kg bw/d Not applicable EU (2007) AOEL Dermal absorption mg/kg bw/d Default values according to guidance on dermal absorption (Efsa 2012): Concentrate Spray dilution (used in formulation) (used in formulation) 360 g/l g/l Dermal absorption endpoints % Acute Toxicity

11 Page 11 of 26 ANGELUS (FH-047), containing 360 g/l clomazone, has a low acute oral and dermal toxicity, is harmful by inhalation, and is corrosive to the rabbit skin and severely irritant to the rabbit eye, but is not a skin sensitiser Operator Exposure Summary of critical use patterns (worst case in bold): Crop F/G 12 Equipment Application rate L product/ha (g a.s./ha) Spray dilution (L/ha) Model Oilseed rape Potato F Tractormounted/trailed boom sprayer: hydraulic nozzles 0.33 L/ha 120 g a.s./ha 0.25 L/ha 90 g a.s./ha 200 BBA Considering the proposed uses, operator systemic exposure was estimated using the German BBA model: Crop Equipment PPE and/or working coverall % AOEL clomazone Oilseed rape Tractor mounted / trailed boom sprayer: hydraulic nozzles Working coverall and gloves during mixing/loading and application 6.5 According to the model calculations, it may be concluded that the risk for the operator using ANGELUS (FH-047) is acceptable with a working coverall (90% protection factor) and gloves during mixing/loading and application. For details of personal protective equipment for operators, refer to the Decision in Appendix Bystander Exposure Bystander exposure was assessed according to EUROPOEM II. Exposure is estimated to be 0.5 % of the AOEL of clomazone. It may be concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to ANGELUS (FH-047) Worker Exposure ANGELUS (FH-047) is used as herbicidal treatment on crops where there is no need to re-enter the treated area after application. It is therefore considered unnecessary to calculate worker exposure. For details of personal protective equipment for workers, refer to the Decision in Appendix Residues and Consumer Exposure The data available are considered sufficient for risk assessment. Any exceedence of the current MRL for clomazone as laid down in Reg. (EU) 396/2005 is not expected. The chronic and short-term intakes of clomazone residues are unlikely to present a public health concern. As far as consumer health protection is concerned, France agrees with the authorisation of the intended uses. 12 Open field or glasshouse

12 Page 12 of 26 According to the available data, the following specific mitigation measures are recommended: - In the case of crop failure, for crops having a short growth cycle, a waiting period of 90 days should be applied. Considering dietary burden and based on the intended uses, no significant modification of the intake was calculated for livestock. Further investigation of residues as well as the modification of MRLs in commodities of animal origin are therefore not necessary. Table 1: Summary for clomazone Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg. (EU) 777/2013 Chronic risk for consumers identified? Acute risk for consumers identified? Comments 1 Oilseed rape Yes Yes (29) Yes Yes Yes No No - 2 Potato Yes Yes (21) Yes Yes Yes No - * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 As residues of clomazone do not exceed the trigger values defined in Reg. (EU) No 283/2013, there is no need to investigate the effect of industrial and/or household processing. Residues in succeeding crops have been sufficiently investigated taking into account the specific circumstances of the cgap uses being considered here. However, considering the possibility of crop failure, it is proposed the following risk mitigation measure: - In the case of a crop failure, do not grow a short-cycle crop (approximately 30 days between sowing/planting and harvest) in the treated plot less than 90 days after an application of clomazone.

13 Page 13 of 26 Table 2: Information on FH-047 Crop PHI for FH- 047 proposed by applicant PHI/withholding period* sufficiently supported for Clomazone PHI for FH- 047 proposed by zrms zrms Comments (if different PHI proposed) Potato F** (BBCH 00-07) Yes F** (BBCH 00-07) - Oilseed rape F** (BBCH 00-05) Yes F** (BBCH 00-05) * Purpose of withholding period to be specified ** F: PHI is defined by the application stage at last treatment (time elapsing between last treatment and harvest of the crop). - Table 3 : Waiting periods before planting succeeding crops Crop group Waiting period before planting succeeding crops Led by clomazone Overall waiting period proposed by zrms for FH-047 Short-cycle crops 90 days In case of crop failure do not grow a short cycle in the treated field less than 90 days after an application of ANGELUS (FH-047) Environmental fate and behaviour The fate and behaviour in the environment have been evaluated according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU conclusions were used to calculate predicted environmental concentration (PEC) values for the active substance and its metabolites for the intended use patterns. In cases where deviations from the EU agreed endpoints were considered appropriate (for example when additional studies are provided), such deviations were highlighted and justified accordingly. The PEC values of clomazone in soil, surface water and groundwater have been assessed according to FOCUS guidance documents, with standard FOCUS scenarios to obtain outputs from the FOCUS models, and the endpoints established in the EU conclusions or agreed in the assessment based on new data provided. PECsoil and PECsw values derived for the active substance are used for the ecotoxicological risk assessment. PECgw values for clomazone do not occur at levels exceeding those mentioned in Regulation (EC) No 1107/2009 and guidance document SANCO 221/2000 on metabolites in groundwater 13.. Therefore no unacceptable risk of groundwater contamination is expected for the intended uses. Based on vapour pressure, information on volatilisation from plants and soil, and DT 50 calculation, no significant contamination of the air compartment is expected for the intended uses Ecotoxicology The ecotoxicological risk assessment of the formulation was performed according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU conclusions for the active substance and its metabolites were used for the intended use patterns. In cases where deviations from the EU agreed endpoints were considered 13 Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council directive 91/414/EEC. Sanco/221/2000-rev10-final, 25 February 2003.

14 Page 14 of 26 appropriate (for example when additional studies are provided), such deviations were highlighted and justified accordingly. Based on the guidance documents, the risks for terrestrial vertebrates, aquatic organisms, bees and other non-target arthropods, earthworms and other soil-macroinvertebrates, soil micro-organisms and terrestrial plants can be considered acceptable for the intended uses Efficacy Considering the data submitted: o The efficacy level of ANGELUS (FH-047) applied in pre-emergence is considered satisfactory for all the requested uses for the control of grasses and broadleaved weeds; o The selectivity level of ANGELUS (FH-047) is considered satisfactory for all the requested uses; o The risks of negative impact on yield, quality, propagation and adjacent crops are considered acceptable; o The risk of negative impact on succeeding crops is considered acceptable. Nevertheless, specific attention should be paid to susceptible replacement crops; o The risk of resistance to clomazone developing or appearing is considered to not require monitoring for the requested uses. 3.2 Conclusions arising from French assessment Taking into account the above assessment, an authorisation can be granted as proposed in Appendix 1 Copy of the product Decision. 3.3 Substances of concern for national monitoring No information stated. 3.4 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Post-authorisation monitoring No further information is required Post-authorisation data requirements The French Decision requests the submission of post-authorisation confirmatory pieces of information within 24 months regarding: - Validation of the analytical method for the determination of clomazone in the preparation Label amendments The draft label proposed by the applicant in Appendix 2 may be corrected with consideration of any new element under points (or 2.2.2), and The label shall reflect the detailed conditions stipulated in the Decision.

15 Page 15 of 26 Appendix 1 Copy of the French Decision

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21 Page 21 of 26 Appendix 2 Copy of the draft product label as proposed by the applicant

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26 Page 26 of 26 Appendix 3 Letter(s) of Access Not applicable.